There was no significant correlation with sVEGFR-2 levels with any endpoint

Author's Conclusions

Sorafenib 400 mg bid is generally well tolerated and shows promising efficacy in patients with advanced, progressive NSCLC, with approximately 60% of pts achieving disease stabilization

Response rate with sorafenib was as least as good as gefitinib and erlotinib

Clinical/Scientific Implications

Sorafenib has comparable activity as a single-agent as other anti-angiogenic therapies and single-agent chemotherapy in NSCLC with similar progression-free survivals:

Sorafenib, 11.9 wks

ZD6474, 11 wks (ASCO 2006)

Sunitinib, 11.3 wks (ASCO 2006)

Docetaxel or Pemetrexate, 12.6 wks

A strength of this study was the incorporation of serum biomarkers to correlate with efficacy

Combination therapies with anti-angiogenic agents with chemotherapies are being explored

A Phase III trial with ~900 patients is being planned in metastatic NSCLC that randomizes patients to either A) carboplatin/taxol x 6 cycles followed by placebo maintenance, or B) carboplatin/taxol x 6 cycles + sorafenib followed by sorafenib maintenance